An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).

Inclusion Criteria:

Phase 1a

• Aged 18 years or older
• Histologically or cytologically confirmed solid tumor or hematologic malignancy
• Life expectancy of 12 weeks or longer
• Must have received ≥ 1 prior treatment regimen
• Must not be a candidate for potentially curative or standard of care approved therapy

Phase 1b

• Aged 18 years or older

• Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion

• Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease

• Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome

• Cohort H: Individuals diagnosed with lymphoma

• Prior therapy:

  • Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
  • Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens
  • Cohort F: May have received any number of prior treatment regimens or be treatment-naïve
  • Cohort H: Must have relapsed from or have been refractory to available treatments

Phase 2

• Aged 18 years or older

• Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome

• Prior therapy:

  • Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)

Exclusion Criteria:

• Prior receipt of a JAK1 inhibitor (Phase 1a only)
• Known active central nervous system metastases and/or carcinomatous meningitis
• Eastern Cooperative Oncology Group (ECOG) performance status > 2
• Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)
• Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation